Radial cutter implant

ABSTRACT

An implant for creating incisions in the tissues surrounding the bladder neck and the urethra of a patient, for relaxing the opening of the bladder, the implant includes a central connector and at least one wire, the wires extend radially outwardly from the center of the central connector, the wires apply continuous pressure on the surrounding tissues, the wires are foldable within an implant sheath for enabling delivery and extraction thereof, the implant is implanted within a restricted location of the urethra for a period of time for creating incisions at the locations where the wires apply pressure on the surrounding tissues.

This application is a Continuation of U.S. application Ser. No.15/782,754, filed Oct. 12, 2017, which is a Continuation of U.S.application Ser. No. 13/141,307, filed Jul. 28, 2011, which is aNational Stage Application of PCT/IL2009/001207, filed Dec. 22, 2009,which claims benefit of U.S. Provisional Application No. 61/288,426,filed Dec. 21, 2009 and U.S. Provisional Application No. 61/139,718,filed Dec. 22, 2008, which applications are incorporated herein byreference. To the extent appropriate, a claim of priority is made to theabove disclosed applications.

FIELD OF THE DISCLOSED TECHNIQUE

The disclosed technique relates to system and method for treating aprostate enlargement (e.g., as a result of benign prostatichyperplasia), in general, and to systems and methods for creatingincisions in the muscles of the bladder neck, in particular.

BACKGROUND OF THE DISCLOSED TECHNIQUE

The prostate is a walnut-sized gland that forms part of the malereproductive system. The prostate is located in front of the rectum andjust below the bladder, where urine is stored. The prostate surroundsthe urethra, the canal through which urine passes out of the body.Prostate enlargement can result from a number of medical problems suchas Benign Prostatic Hyperplasia (BPH), prostatic Bladder NeckObstruction (BNO) and the like. The enlarged prostate applies pressureon the urethra and damages bladder function.

Transurethral incision of the prostate (TUIP) is an endoscopic procedureusually performed under general anaesthetic in which a surgeon employsan instrument (e.g., a scalpel, a laser beam generator and an electricalcurrent actuator) inserted into the urethra for making incisions in thebladder neck where the prostate meets the bladder (i.e., morespecifically in the midline to the level of the verumontanum). Incisingthe muscles in the bladder neck area relieves the obstructive effect ofthe prostate on the bladder neck and prostatic urethra and relaxes theopening of the bladder, thus decreasing resistance to the flow of urineout of the bladder. It is noted that, no tissue is removed during TUIP.

Infarction is a process resulting in a macroscopic area of necrotictissue in some organ caused by loss of adequate blood supply. Theinadequate blood supply can result from pressure applied to the bloodvessels. Even by applying a relative small but continuous pressure on atissue, one can block the tiny blood vessels within the tissue andinduce infarction.

PCT patent application publication No. WO 2006/040767 A1 to theinventor, entitled “Prostate Treatment Stent” is directed at a tissuedissecting implant kit. The tissue dissecting implant kit includes animplant and a sterile package. The implant includes a plurality of ringselastically coupled there-between. An elastic pressure is applied ontissue caught between adjacent rings. The sterile package encompassesthe implant. The implant has different distances between adjacent ringsalong its length. Alternatively, the implant has different materialthickness or cross-section shape along its length. It is noted that, thetissue dissecting implant kit applies pressure on tissue caught betweenadjacent rings until the tissue is cut away or until the tissue fallsoff.

U.S. Pat. No. 5,209,725 issued to Roth, and entitled “Prostatic UrethraDilatation Catheter System and Method”, is directed to an instrument forperforming a transurethral balloon dilatation procedure of the prostate.The balloon dilatation instrument includes a hollow catheter and opticalviewing means. The hollow catheter includes a shaft, an inflatableoptically transparent balloon, and at least one suitable visiblemarking.

The distal end portion of the shaft is made of an optically transparentmaterial. The inflatable optically transparent balloon is coupled withthe distal end portion of the shaft, and is sized to dilate theprostatic urethra. The at least one suitable visible marking ispositioned on the catheter proximally to the balloon, such that themarking can be visualized relative to a predetermined anatomicallandmark (e.g., verumon tanum). In this manner, proper positioning ofthe balloon, relative to the prostatic urethra, is performed prior toand during the dilation of the prostatic urethra. The optical viewingmeans, is slidable within the catheter, for visibly viewing the markingintra-luminally from within the catheter. The balloon is correctlylocated relative to the prostatic urethra. The balloon is inflated so asto dilate the prostatic urethra without damaging the external sphincterat the apex of the prostate.

U.S. Pat. No. 5,499,994 issued to Tihon et al., and entitled “DilationDevice for the Urethra”, is directed to a dilation device for opening aportion of an obstructed urethra. The dilation device includes an innerhollow tubular core and an outer confining covering. The inner hollowtubular core defines a lumen therein. The lumen is a conduit ofsufficient diameter to permit urine to flow freely there-through fromthe bladder. The core is substantially non-collapsible. The outerconfining covering is capable of expanding radially outwardly to apredetermined extent. The covering has a length of at least partiallythat of the obstructed portion of the urethra. The dilation device canfurther include retractable spikes for anchoring the device in itsintended position.

SUMMARY OF THE PRESENT DISCLOSED TECHNIQUE

It is an object of the disclosed technique to provide a novel method andsystem for creating incisions in the muscles of the bladder neck byimplanting a radial cutter implant which applies continuous pressure onthe muscles of the bladder neck.

In accordance with the disclosed technique, there is thus provided animplant for creating incisions in the tissues surrounding the bladderneck and the urethra of a patient, for relaxing the opening of thebladder. The implant includes a central connector and at least one wire.The wires extend radially outwardly from the center of the centralconnector. The wires apply continuous pressure on the surroundingtissues. The wires are foldable within an implant sheath for enablingdelivery and extraction thereof. The implant is implanted within arestricted location of the urethra for a period of time for creatingincisions at the locations where the wires apply pressure on thesurrounding tissues.

In accordance with another embodiment of the disclosed technique, thereis thus provided a method for creating incisions in the tissuessurrounding the bladder neck and the urethra of a patient for relaxingthe opening of the bladder. The method includes the procedures ofdelivering a radial cutter implant, releasing the radial cutter,applying continuous pressure, and extracting the radial cutter implant.The radial cutter implant is delivered to a constricted location withinthe urethra by employing a delivery system. After the radial cutterimplant is delivered the delivery system is removed. The continuouspressure is applied on the surrounding tissues by employing the radialcutter implant. At the appearance of a predetermined condition, theradial cutter implant is extracted from the patient.

In accordance with a further embodiment of the disclosed technique,there is thus provided a delivery system for delivering a radial cutterimplant. The delivery system includes a positioning tube, a balloontube, a balloon, an internal delivery tube, and an implant sheath. Theballoon tube slidably goes through the portioning tube. The balloon iscoupled with a distal end of the balloon tube. The balloon is inflatablevia the balloon tube. The radial cutter implant is coupled with a distalend of the internal delivery tube. The implant sheath is externallyslidably coupled with the internal delivery tube for holding the radialcutter implant at a folded configuration during delivery and extractionthereof. A physician inserts the positioning tube and the balloon tubeinto a urethra of a patient until the balloon is positioned inside abladder of the patient. The physician inflates the balloon and pulls thepositioning tube and the balloon tube in the distal direction until theballoon is blocked by a bladder neck of the patient. The physiciandeflates the balloon. The physician removes the balloon tube whilekeeping the positioning tube in place. The physician inserts theinternal delivery tube including the implant sheath, having the radialcutter implant folded therein. The physician positions the radial cutterimplant within a constricted location of the urethra, according to theposition of the positioning tube. The physician pulls the implant sheathand exposes the radial cutter implant. The radial cutter implant expandsand applies pressure on surrounding tissues. The physician removes theinternal delivery tube, including the implant sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed technique will be understood and appreciated more fullyfrom the following detailed description taken in conjunction with thedrawings in which:

FIG. 1 is a schematic illustration of an overtube for determining thelocation of a bladder neck of a patient and delivering a radial cutterimplant thereto, constructed and operative in accordance with anembodiment of the disclosed technique;

FIG. 2 is a schematic illustration of a delivery for delivering a radialcutter implant to the bladder neck of a patient, constructed andoperative in accordance with another embodiment of the disclosedtechnique;

FIGS. 3A, 3B and 3C are schematic illustrations of a system fordelivering a radial cutter implant to the bladder neck of a patient,constructed and operative in accordance with a further embodiment of thedisclosed technique;

FIGS. 4A, 4B and 4C are schematic illustrations of a delivery fordelivering a radial cutter implant, constructed and operative inaccordance with another embodiment of the disclosed technique;

FIG. 5A is a schematic illustration of a coupler for coupling a radialcutter implant with an internal tube of a delivery system, constructedand operative in accordance with a further embodiment of the disclosedtechnique;

FIG. 5B is a schematic illustration of a coupler for coupling a radialcutter implant with an internal tube of a delivery system, constructedand operative in accordance with another embodiment of the disclosedtechnique;

FIGS. 5C and 5D are schematic illustrations of a coupler for coupling aradial cutter implant with an internal tube of a delivery system,constructed and operative in accordance with a further embodiment of thedisclosed technique;

FIG. 5E is a schematic illustration of a coupler for coupling a radialcutter implant with an internal tube of a delivery system, constructedand operative in accordance with another embodiment of the disclosedtechnique;

FIGS. 6A and 6B are schematic illustrations of a radial cutter implant,constructed and operative in accordance with a further embodiment of thedisclosed technique;

FIGS. 7A and 7B are schematic illustrations of a radial cutter implant,constructed and operative in accordance with another embodiment of thedisclosed technique;

FIG. 8 is a schematic illustration of a radial cutter implant,constructed and operative in accordance with a further embodiment of thedisclosed technique;

FIGS. 9A and 9B are schematic illustrations of a radial cutter implant,constructed and operative in accordance with another embodiment of thedisclosed technique;

FIGS. 10A and 10B are schematic illustrations of a radial cutterimplant, constructed and operative in accordance with a furtherembodiment of the disclosed technique;

FIGS. 11A and 11B are schematic illustrations of a radial cutterimplant, constructed and operative in accordance with another embodimentof the disclosed technique;

FIG. 12 is a schematic illustration of a radial cutter implant,constructed and operative in accordance with a further embodiment of thedisclosed technique;

FIGS. 13A, 13B and 13C are schematic illustrations of a radial cutterimplant, constructed and operative in accordance with another embodimentof the disclosed technique;

FIG. 14 is a schematic illustration of radial cutter implant,constructed and operative in accordance with a further embodiment of thedisclosed technique;

FIGS. 15A and 15B are schematic illustrations of a radial cutterimplant, constructed and operative in accordance with another embodimentof the disclosed technique;

FIGS. 16A to 16D are schematic illustrations of a redial cutter implant,constructed and operative in accordance with a further embodiment of thedisclosed technique;

FIG. 17 is a schematic illustration of a redial cutter implant,positioned within a bladder neck of a patient, constructed and operativein accordance with another embodiment of the disclosed technique; and

FIG. 18 is a schematic illustration of a method for creating incisionsin the muscles of the bladder neck by infarction, operative inaccordance with a further embodiment of the disclosed technique.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The disclosed technique overcomes the disadvantages of the prior art byproviding an implant for applying small yet continuous pressure on thetissues of the bladder neck sphincter (i.e., as well as tissues of theurethra and the prostate gland) by a plurality of wires. The pressureinduces infarction in the tissues (i.e., tissues of the bladder neck,urethra, and prostate gland) which creates a plurality of desiredincisions (i.e., each of the wires creates an incision). The incisionsrelive a prostate enlargement problem by cutting through the tissues andextending the urinal passage (i.e., the wires both incise and extend thetissues in the radial direction from the urethra axis outwardly). Thedisclosed technique further includes a delivery and deployment systemfor the incising implant. It is noted that, in this application, aradial cutter implant which applies pressure on the tissues of thebladder neck, further applies pressure on the tissues of the prostateand urethra unless specifically mentioned otherwise along the text.

The terms proximal and distal refer to directions relative to the bodyof the patient. In particular, the term proximal refers to a directionfacing toward the center of the body of the patient. The term distalrefers to a direction facing the periphery of the body of the patient,opposite of the proximal direction. For example a catheter is insertedinto the urethra of the patient with the proximal end thereof first.

Reference is now made to FIG. 1, which is a schematic illustration of anovertube, generally referenced 100, for determining the location of abladder neck of a patient and delivering a radial cutter implantthereto, constructed and operative in accordance with an embodiment ofthe disclosed technique. Overtube 100 includes a balloon 102, a balloontube 104 (i.e., balloon Foley-catheter 104), and a positioning tube 106.Balloon 102 is coupled around balloon tube 104. Balloon tube 104slidably goes through positioning tube 106.

Overtube 100 enables a physician (not shown) to deploy a radial cutterimplant (e.g., radial cutter implant 320 of FIG. 6A) at the bladder neckof a patient (both bladder neck and patient are not shown). Thephysician inserts overtube 100 through the urethra of the patient untilballoon 102 is positioned within the bladder (e.g., bladder 152 of FIG.3A) of the patient. The physician inflates balloon 102 via balloon tube104. When balloon 102 is inflated, the physician pulls overtube 100 inthe distal direction (i.e., the physician pulls overtube 100 backtowards him) until inflated balloon 102 is blocked by the bladder neck.Thus, the physician determines the exact position of the bladder neck ofthe patient. The physician deflates balloon 102 and removes balloon tube104 from overtube 100 while leaving positioning tube 106 in place.Alternatively, the physician can determine the location of the bladderneck, and position positioning tube 106 accordingly, by employing anymethod known in the art, such as Ureteroscopy, Ultra-Sound imaging,fluoroscopy, and the like.

Reference is now made to FIG. 2, which is a schematic illustration of adelivery system, generally referenced 120, for delivering a radialcutter implant to the bladder neck of a patient, constructed andoperative in accordance with another embodiment of the disclosedtechnique. Delivery system 120 includes an implant sheath 122, anexternal tube 124, an external tube handle 126, an internal tubeproximal end 128, an internal tube 130, and an internal tube handle 132.Implant sheath 122 is coupled with the proximal end of external tube124. External tube handle 126 is coupled with the distal end of externaltube 124. Internal tube proximal end 128 is coupled with the proximalend of internal tube 130. Internal tube 130 slidably goes throughexternal tube 124. Internal tube handle 132 is coupled with the distalend of internal tube 130.

A radial cutter implant (not shown—e.g., radial cutter implant 320 ofFIG. 6A) is detachably coupled with internal tube proximal end 128 suchthat the implant is covered by implant sheath 122. In particular, andrelating to the configuration of delivery system 120, as depicted inFIG. 2, internal tube 130 slides along external tube 124 in the distaldirection until implant sheath 122 is positioned adjacent internal tubeproximal end 128. In this manner implant sheath 122 covers the radialcutter implant, thereby restraining it.

The physician inserts delivery system 120 into the urethra of thepatient through positioning tube 106 of FIG. 1. The physician employspositioning tube 106 (FIG. 1) for positioning the radial cutter implantat the location of the bladder neck (i.e., or of the restricted locationof the urethra) as located by employing overtube 100. Once the radialcutter implant is positioned within the bladder neck, the physicianexposes the radial cutter implant, as detailed further with reference toFIGS. 3A to 3C.

Reference is now made to FIGS. 3A, 3B and 3C which are schematicillustrations of a system, generally referenced 150, for delivering aradial cutter implant to the bladder neck of a patient, constructed andoperative in accordance with a further embodiment of the disclosedtechnique. With reference to FIG. 3A, delivery system 150 includes anovertube 164, substantially similar to overtube 100 of FIG. 1. Overtube164 includes a balloon 158, a balloon tube 160 and a positioning tube162. Each of balloon 158, balloon tube 160 and positioning tube 162 issubstantially similar to balloon 102, balloon tube 104 and positioningtube 106 of FIG. 1, respectively.

The physician inserts overtube 164 into a penis 182 of the patient andthrough a urethra 154 (FIG. 3B) of the patient, until balloon 158 ispositioned within a bladder 152 of the patient. The physician inflatesballoon 158 via balloon tube 160. Once balloon 158 is inflated, thephysician pulls back overtube 164 (i.e., in the distal direction) untilballoon 158 is blocked by bladder neck 156 of the patient. The physiciandeflates balloon 158 and removes balloon tube 160 from within overtube164 while keeping positioning tube 162 in place. Thus, the physicianlocates the exact position of bladder neck 156.

With reference to FIG. 3B, delivery system 150 further includes adelivery 176, substantially similar to delivery system 120 of FIG. 2.Delivery 176 includes an implant sheath 166, an external tube 168(located within positioning tube 162 and is not shown in the figure), anexternal tube handle 170, an internal tube 172, and an internal tubehandle 174. Delivery system 150 further includes a radial cutter implant178 within implant sheath 166. Each of implant sheath 166, external tube168, external tube handle 170, internal tube 172, and internal tubehandle 174, is substantially similar to each of implant sheath 122,external tube 124, external tube handle 126, internal tube 130, andinternal tube handle 132, respectively.

After removing balloon tube 160 from overtube 164 (FIG. 3A), thephysician inserts delivery 176 into positioning tube 162. The physicianpositions delivery 176 such that radial cutter implant 178 is positionedaccording to the position of positioning tube 162. The physician pullsexternal tube handle 170 for exposing radial cutter implant 178. Radialcutter implant 178 expands until it is attached to the walls of bladderneck 156 (i.e., to the muscles of bladder neck 156 and the surroundingtissues). Radial cutter implant 178 starts applying pressure to thewalls of bladder neck 156 and urethra 154 (i.e., as well as on tissuesof the prostate—not shown—as detailed herein above). In the example setforth in FIG. 3B, radial cutter implant 178 is self expanding.Alternatively, radial cutter implant 178 is expanded manually by thephysician by employing an expander (i.e., a device for expanding implant178 as known in the art—for example, a balloon).

With reference to FIG. 3C, radial cutter implant 178 is positionedwithin urethra 154 in an expanded configuration. The physician pullspositioning tube 162 out of the patient and leaves radial cutter implantwithin urethra 154 for a predetermined period of time (as detailedherein below—e.g., two weeks). Radial cutter implant 178 appliespressure on the walls of the surrounding tissues (e.g., bladder neck156, urethra 154, and the prostate gland—not shown) incising thesurrounding tissues over the predetermined period of time. The prolongedincision of the tissue, created by continuous pressure, decreases thepain involved in the procedure. Furthermore, by performing the incisionsvia continuous pressure (i.e., via infarction), bleeding is avoided.

The period of time, radial cutter implant 178 is implanted in theurethra of the patient, is determined by the physician at leastaccording to the diagnosis of the patient (i.e., predetermined period oftime). Alternatively, the time period is determined according toobservations of the radial cutter implant effect over time (i.e., realtime period determination), or any other way known in the art. Furtheralternatively, the time period ranges between one hour and twenty ninedays.

Reference is now made to FIGS. 4A, 4B and 4C, which are schematicillustrations of a delivery, generally referenced 200, for delivering aradial cutter implant, constructed and operative in accordance withanother embodiment of the disclosed technique. With reference to FIG.4A, delivery 200 is substantially similar to delivery system 120 of FIG.2. Delivery 200 includes an implant sheath 202, an external tube 204, anexternal tube handle 206, an internal tube 208, and an internal tubehandle 210. Each of implant sheath 202, external tube 204, external tubehandle 206, internal tube 208, and internal tube handle 210 issubstantially similar to each of implant sheath 122, external tube 124,external tube handle 126, internal tube 130, and internal tube handle132 of FIG. 2, respectively.

Implant sheath 202 is coupled with the proximal end of external tube204. External tube handle 206 is coupled with the distal end of externaltube 204. A radial cutter implant 212 (FIG. 4B) is coupled, at a foldedconfiguration thereof, with the proximal end of internal tube 208 and iscovered by implant sheath 202. Internal tube 208 is slidably coupledwith external tube 204. Internal tube handle 210 is coupled with thedistal end of internal tube 208.

With reference to FIG. 4B, a physician (not shown) pulls external tube204 via external tube handle 206 while keeping internal tube 208 inplace. Thus, external tube 204 slides along internal tube 208 in thedistal direction and implant sheath 202 is removed from radial cutterimplant 212.

With reference to FIG. 4C, once implant sheath 202 is fully removed fromradial cutter implant 212 (i.e., radial cutter implant is fullyexposed), radial cutter implant 212 expands. In the example set forth inFIG. 4C, radial cutter implant 212 is self-expanding. Alternatively,radial cutter implant 212 is expanded manually by the physicianemploying an implant expander (not shown).

The physician leaves radial cutter implant 212 within the body of thepatient for a predetermined period of time. When the physician wishes toremove radial cutter implant 212, the physician inserts delivery 200into the urethra (not shown) of the patient. The physician couples theproximal end of internal tube 208 with radial cutter implant 212 byemploying a coupler (not shown—e.g., coupler 240 of FIG. 5A). Thephysician pulls back internal tube 208 while keeping external tube 204in place. Thus, radial cutter implant 212 is folded within, and isrestrained by, implant sheath 202 and can be extracted from the body(i.e., the bladder neck and the urethra) of the patient, withoutdamaging the tissues of the urethra. It is noted that, the delivery ofradial cutter implant 212 and the extraction thereof are substantially areveres duplicates of each other. In other words, the steps performedupon delivery are repeated in a reveres order upon extraction.

Reference is now made to FIGS. 5A, 5B, 5C, 5D and 5E. FIG. 5A is aschematic illustration of a coupler, generally referenced 240, forcoupling a radial cutter implant with an internal tube of a deliverysystem, constructed and operative in accordance with a furtherembodiment of the disclosed technique. FIG. 5B is a schematicillustration of a coupler, generally referenced 250, for coupling aradial cutter implant with an internal tube of a delivery system,constructed and operative in accordance with another embodiment of thedisclosed technique. FIGS. 5C and 5D are schematic illustrations of acoupler, generally referenced 260, for coupling a radial cutter implantwith an internal tube of a delivery system, constructed and operative inaccordance with a further embodiment of the disclosed technique. FIG. 5Eis a schematic illustration of a coupler, generally referenced 280, forcoupling a radial cutter implant with an internal tube of a deliverysystem, constructed and operative in accordance with another embodimentof the disclosed technique.

With reference to FIG. 5A, coupler 240 includes a female portion 246 anda male portion 248. Male portion 248 is inserted into female portion 246and is attached to female portion by screwing mechanism. In other words,the external circumference of male portion 248 is similar to that of ascrew and the internal circumference of female portion 246 is similar tothat of a nut. In the example set forth in FIG. 5A, female portion 246is coupled with the distal end of a radial cutter implant 242 (e.g.,radial cutter implant 320 of FIG. 6A), and male portion 248 is coupledwith the proximal end of an internal tube 244 of a delivery system(e.g., internal tube 208 of FIG. 4A). Alternatively, female portion 246is coupled with the proximal end of internal tube 244, and male portion248 is coupled with the distal end of radial cutter implant 242.

With reference to FIG. 5B, coupler 250 includes a loop 256 and a hook258. Hook 258 is inserted into loop 256 such that the physician is ableto pull both hook 258 and loop 256 when pulling either of them. In theexample set forth in FIG. 5B, loop 256 is coupled with the distal end ofa radial cutter implant 252, and hook 258 is coupled with the proximalend of an internal tube 254. Alternatively, loop 256 is coupled with theproximal end of internal tube 254, and hook 258 is coupled with thedistal end of radial cutter implant 252.

With reference to FIG. 5C, coupler 260 includes a dilating tip 266 and arecessed tube 262 (i.e., a tube which is sliced for forming a pair ofpincers at the end thereof—the pincers are not referenced). Recessedtube 262 is coupled with the proximal end of a delivery system (e.g.,delivery system 200 of FIG. 4A). Dilating tip 266 is coupled withrecessed tube 262, such that dilating tip can be pulled into a recess264 of recessed tube 262 and pushed out of recess 264 of recessed tube262. When dilating tip 266 is positioned within recess 264, dilating tip266 expands the diameter of recessed tube 262. Recessed tube 262 iscoupled with the proximal end of an internal tube 262.

With reference to FIG. 5D, a distal end of a radial cutter implant 274is coupled with a bottleneck 272. Bottleneck 272 includes an aperture270 positioned approximately in the middle thereof. From the distal sideof aperture 270 a gradually narrowing niche 268 is culminating inaperture 270. The diameter of aperture 270 is slightly larger than thediameter of recessed tube 260 and the diameter of dilating tip 266. Thephysician pushes dilating tip 266 and recessed tube 262 through aperture270. After recessed tube 262 and dilating tip 266 are positionedproximally to aperture 270, the physician pulls dilating tip 266 intorecess 264 for enlarging the diameter of recessed tube 262. When thephysician pulls recessed tube 262 back in the distal direction, radialcutter implant 274 is pulled there-along (i.e., enlarged recessed tube262 is blocked by aperture 270 of bottle neck 272). When the physicianpushes dilating tip 266 away from recess 264, recessed tube 262 returnsto the original diameter thereof. Thus, recessed tube 262 and dilatingtip 266 can go through bottleneck 272 (i.e., through aperture 270).

In the example set forth in FIGS. 5C and 5D, recessed tube 262 anddilating tip 266 are coupled with an internal tube (not referenced) ofthe delivery system, and bottle neck 272 is coupled with a radial cutterimplant 274. Alternatively, recessed tube 262 and dilating tip 266 arecoupled with radial cutter implant 274, and bottleneck 272 is coupledwith the internal tube.

With reference to FIG. 5E, coupler 280 includes a rigid ball 286 and aflexible socket 292. Flexible socket 292 includes a gradually narrowingopening 288 and a spherical niche 290. When rigid ball 286 is pushedagainst flexible socket 292, rigid ball 286 enters through graduallynarrowing opening 288 and expands the proximal end thereof when enteringspherical niche 290. Once rigid ball 286 is positioned inside flexiblesocket 290 (i.e., rigid ball 286 is securely coupled with flexiblesocket 292), the physician can pull flexible socket 292, and rigid ball286 is pulled there-along. In the example set forth in FIG. 5E, rigidball 286 is coupled with the distal end of a radial cutter implant 282,and flexible socket 292 is coupled with the proximal end of an internaltube 284. Alternatively, rigid ball 286 is coupled with the proximal endof internal tube 284, and flexible socket 292 is coupled with the distalend of radial cutter implant 282.

Reference is now made to FIGS. 6A and 6B, which are schematicillustrations of a radial cutter implant, generally referenced 320,constructed and operative in accordance with a further embodiment of thedisclosed technique. With reference to FIG. 6A, radial cutter implant320 is depicted from a side view perspective. Radial cutter implant 320includes a distal end 322, three wires 326, 328 and 330, and a proximalend 324. Three wires 326, 328 and 330 are coupled between distal end 322and proximal end 324. Distal end 322 is coupled with a coupler (e.g.,coupler 240, 250, 260, and 280 of FIGS. 5A, 5B, 5C, and 5E,respectively).

Proximal end 324 is tapered for dilating the urethra of the patientduring delivery of radial cutter implant 320. The shape of each of wires326, 328 and 330, is substantially a portion of a circle. Each of wires326, 328 and 330 is made from a Shape Memory Alloy (SMA), such as NickelTitanium alloy (Nitinol). Alternatively, each of wires 326, 328 and 330is made from any material which is flexible enough to be folded withinan implant sheath and is strong enough (e.g., 0.5 Newton) to applypressure on the surrounding tissues and induce infarction. Each of wires326, 328 and 330 is flexible such that it can be straightened in orderfor radial cutter 320 to be folded within an implant sheath (e.g.,implant sheath 202 of FIG. 4A—not shown). Each of wires 326, 328 and 330springs back to the portion of the circle stance, once not limited by anobstacle (e.g., implant sheath 202 of FIG. 4A, the walls of the bladderneck of the patient). In this manner, when radial cutter implant 320 ispositioned within the bladder neck of the patient, wires 326, 328 and330, apply pressure to the surrounding tissues (e.g., bladder neck,urethra and prostate). With reference to FIG. 6B, radial cutter implant320 is depicted from a bottom view perspective.

Alternatively, implant 320 is made of biodegradable materials, such thatthere is no need to remove implant 320 from the body of the patient. Inthis manner, implant 320 is constructed such it biodegrades, ceases fromfunctioning and dissolves within the patient after the predeterminedperiod of time, or after a triggering event initiated by the physician,as known in the art.

Reference is now made to FIGS. 7A and 7B, which are schematicillustrations of a radial cutter implant, generally referenced 350,constructed and operative in accordance with another embodiment of thedisclosed technique. With reference to FIG. 7A, radial cutter implant350 is depicted from a side view perspective. Radial cutter implant 350includes a distal end 352 and three wires 354, 356, and 358. Each ofdistal end 352 and wires 354, 356, and 358, is substantially similar toeach of distal end 322, and wires 326, 328, and 330 of FIG. 6A,respectively. Wires 354, 356, and 358 are not coupled there-between atthe proximal end thereof. Radial cutter implant 350 operates in asubstantially similar manner to that of radial cutter implant 320. Withreference to FIG. 7B, radial cutter implant 350 is depicted from abottom view perspective.

Reference is now made to FIG. 8, which is a schematic illustration of aradial cutter implant, generally referenced 380, constructed andoperative in accordance with a further embodiment of the disclosedtechnique. Radial cutter implant 380 includes a distal end 382 and threewires 384, 386 and 388. Distal end 382 is substantially similar todistal end 322 of FIG. 6A. Each of wires 384, 386 and 388, issubstantially similar to each of wires 326, 328 and 330 of FIG. 6A,respectively. Each of wires 384, 386 and 388 is in the shape of half aheart shape (i.e., the shape of a single side of a heart shape). Each ofwires 384, 386 and 388 extends from the distal side of distal end 382and U-turns to project proximally from distal end 382. In other words,each of wires 384, 386 and 388 is bent such that it is coupled with thedistal side of distal end 382 and it extends proximally from distal end382. Radial cutter implant 380 operates in a substantial similar mannerto that of radial cutter implant 320 of FIG. 6A.

Reference is now made to FIGS. 9A and 9B, which are schematicillustrations of a radial cutter implant, generally referenced 410,constructed and operative in accordance with another embodiment of thedisclosed technique. With reference to FIG. 9A, radial cutter implant410 is depicted from a side view perspective. Radial cutter implant 410includes a distal end 412, a proximal end 414 and two wires 416 and 418.Wires 416 and 418 are coupled between distal end 412 and proximal end414. Distal end 412 is substantially similar to distal end 322 of FIG.6A. Each of wires 416 and 418 is substantially similar to wire 326 ofFIG. 6A. Each of wires 416 and 418 is coupled with the distal side ofdistal end 412 and with the proximal side of proximal end 414. Each ofwires 416 and 418 is substantially C shaped. Radial cutter implant 410operates in a substantial similar manner to that of radial cutterimplant 320 of FIG. 6A. With reference to FIG. 9B, radial cutter implant410 is depicted from a bottom view perspective.

Reference is now made to FIGS. 10A and 10B, which are schematicillustrations of a radial cutter implant, generally referenced 440,constructed and operative in accordance with a further embodiment of thedisclosed technique. With reference to FIG. 10A, radial cutter implant440 is depicted from a side view perspective. Radial cutter 440 includesa tube 442 and three wires 444, 446 and 448 (wire 448 is hidden behindtube 442 and is depicted in FIG. 10B).

Each of wires 444, 446 and 448 is substantially similar to each of wires326, 328 and 330 of FIG. 6A. Each of wires 444, 446 and 448 is in theshape of a portion of a circle. The distal end of each of wires 444, 446and 448 is coupled with the distal portion of tube 442, and the proximalend of each of wires 444, 446 and 448 is coupled with the proximalportion of tube 442. Tube 442 enables a clear passage of urine from thebladder of the patient through the bladder neck and into the urethra.The distal end of tube 442 can be coupled with an internal tube of adelivery system (e.g., delivery system 150 of FIGS. 3A to 3C) byemploying a coupler (e.g., coupler 240 of FIG. 5A). Radial cutterimplant 440 operates in a substantial similar manner to that of radialcutter implant 320. With reference to FIG. 10A, radial cutter implant440 is depicted from a bottom view perspective.

Reference is now made to FIGS. 11A and 11B, which are schematicillustrations of a radial cutter implant, generally referenced 470,constructed and operative in accordance with another embodiment of thedisclosed technique. With reference to FIG. 11A, radial cutter implant470 is depicted from an isometric perspective. Radial cutter implant 470includes a distal end 472, four butterfly wing shaped wires 474, 476,478 and 480, and a proximal end 482. Distal end 472 is substantiallysimilar to distal end 322 of FIG. 6A. Proximal end 482 is substantiallysimilar to proximal end 324 of FIG. 6A. Each of butterfly wing shapedwires 474, 476, 478 and 480 is coupled between distal end 472 andproximal end 482. Each of butterfly wing shaped wires 474, 476, 478 and480 is flexible such that it can be folded within an implant sheath(e.g., implant sheath 402 of FIG. 4A).

The shape of each of butterfly wing shaped wires 474, 476, 478 and 480enables radial cutter implant 470 to be fixed in the bladder neck of thepatient without moving. Radial cutter implant 470 is narrower at themiddle thereof than at the distal and proximal portions thereof (i.e.,butterfly wing shaped wires 474, 476, 478 and 480). In this manner, thenarrow middle of radial cutter implant 470 is positioned at the bladderneck of the patient. The proximal portion of radial cutter implant 470is positioned within the bladder of the patient, and the distal portionof radial cutter implant 470 is positioned within the urethra of thepatient, such that radial cutter implant 470 is fixed in place. A string484 is looped around distal end 482 for enabling extraction of radialcutter implant 470. The physician (not shown) can employ the string 484for guiding a delivery system (e.g., delivery system 150 of FIGS. 3A to3C) for the extraction of radial cutter implant 470 (i.e., string 484 isemployed as a guide wire). Radial cutter implant 470 operates in asubstantially similar manner to that of radial cutter implant 322 ofFIG. 6A. With reference to FIG. 11B, radial cutter implant 470 isdepicted from a side view perspective.

Reference is now made to FIG. 12, which is a schematic illustration of aradial cutter implant, generally referenced 500, constructed andoperative in accordance with a further embodiment of the disclosedtechnique. Radial cutter implant 500 includes a right side portion 502and a left side portion 504. Right side portion 502 is coupled with leftside portion 504 at the proximal and distal ends thereof. Each of rightside portion 502 and left side portion 504 is butterfly wing shaped.Each of right side portion 502 and left side portion 504 issubstantially similar to butterfly wing shaped wire 474 of FIG. 11A.Radial cutter implant 500 is positioned in the bladder neck and is fixedin place in a substantial similar manner to that of radial cutterimplant 470 of FIG. 11A. A string 506 is coupled with the distal end ofradial cutter implant 500 for enabling extraction of radial cutterimplant 500, for guiding a delivery system for the extraction procedure,or as anchoring device (i.e., string 506 is anchored outside of the bodyof the patient and prevents radial cutter implant 500 from moving).

In the examples set forth in FIGS. 6A, 6B, 7A, 7B, 8, 9A, 9B, 10A, 10B,11A, 11B and 12, each of the radial cutter implants includes two to fourwires. A radial cutter implant according to the disclosed techniqueshould include at least one wire, radially extending outwardly from thecenter of the radial cutter implant, for applying pressure on thesurrounding tissues. The radial cutter implant can include largernumbers of wires than four, such as five wires, six wires, and the like.The shape of the wires can be a portion of a circle, a butterfly wingshape, a polygon, and the like. The cross-section of the wires is round,rectangular, triangular, or any polygonal shaped.

In the examples set forth in FIGS. 6A, 6B, 7A, 7B, 8, 9A, 9B, 10A, 10B,11A, 11B and 12, each of the radial cutters include either a distal endor a tube coupled with the distal end of the wires. It is noted that, aradial cutter implant according to the disclosed technique includes atleast one central connector (e.g., distal end 322 of FIG. 6A or tube 442of FIG. 10A) connecting the wires. It is further noted that the centralconnector can be connected to the wires at the proximal end of thewires, at the distal end of the wires, and at any point in the middle ofthe wires.

Reference is now made to FIGS. 13A, 13B and 13C, which are schematicillustrations of a radial cutter implant, generally referenced 520,constructed and operative in accordance with another embodiment of thedisclosed technique. With reference to FIG. 13A, radial cutter implant520 is depicted from a side view perspective. Radial cutter implant 520is substantially similar to radial cutter implant 440 of FIG. 10A.Radial cutter implant 520 includes a tube 522 and three wires 524, 526and 528. Each of wires 524, 526 and 528 includes two barbs 530. Tube 522is a catheter which allows urine to pass there-through. Each of barbs530 penetrates into the surrounding tissues (i.e., the tissuessurrounding implant 520) for anchoring radial cutter implant 520 inplace (i.e., for preventing migration of radial cutter implant 520 intothe bladder or into the urethra). When radial cutter implant 520 isextracted from the bladder neck (i.e., pulled back in the distaldirection), barbs 530 are pulled out of the surrounding tissues. Withreference to FIG. 13B, FIG. 13B depicts an enlarged view portion 532 ofradial cutter implant 520. Each of barbs 530 is directed in the proximaldirection for preventing radial cutter 520 from moving in the proximaldirection, from the bladder neck into the bladder (i.e., keeping radialcutter implant 520 anchored in place). With reference to FIG. 13C,radial cutter implant 520 is depicted from a bottom view perspective.

It is noted that, the number of wires including barbs can vary.Furthermore, the number of barbs on a wire can vary. For example, aradial cutter implant including five wires, three of which includes twobarbs each, a fourth wire includes four barbs, and the fifth wireincludes no barbs.

Reference is now made to FIG. 14, which is a schematic illustration ofradial cutter implant, generally referenced 550, constructed andoperative in accordance with a further embodiment of the disclosedtechnique. Radial cutter implant 550 includes a distal end 552 and twowires 554 and 556. Radial cutter implant 550 is substantially similar toradial cutter implant 350 of FIG. 7A, except for the number of wires(radial cutter implant 350 includes three wires and radial cutterimplant 550 includes two wires). Each of wires 554 and 556 includes twobarbs 558 and 560. The direction of extension of barbs 558 is differentfrom the direction of extension of barbs 560 for enabling a strongerfixation into the bladder neck (i.e., stronger than a configuration ofsimilar extending barbs).

Reference is now made to FIGS. 15A and 15B, which are schematicillustrations of a radial cutter implant, generally referenced 580,constructed and operative in accordance with another embodiment of thedisclosed technique. With reference to FIG. 15A, radial cutter implant580 is depicted from an isometric perspective. Radial cutter implantincludes a tube 582, three wires 584, 586 and 588, and three wings 590,592 and 594. Each of wires 584, 586 and 588 includes two barbs 596. Eachof wires 584, 586 and 588 is coupled with the distal end of tube 582.Each of wings 590, 592 and 594 is coupled between tube 582 and each ofwires 584, 586 and 588, respectively.

Each of wires 584, 586 and 588, and each of wings 590, 592 and 594 isflexible for enabling radial cutter implant 580 to be folded within animplant sheath (e.g., implant sheath 202 of FIG. 4A). Each of barbs 596is substantially similar to each of barbs 558 of FIG. 14. While radialcutter implant 580 is implanted within the patient, tissue can growaround each of wires 584, 586 and 588. Tissue growth around wires 584,586 and 588 complicates the extraction of radial cutter implant 580 andprevent the widening effect of implant 580. Wings 590, 592 and 594prevent tissue from growing around wires 584, 586 and 588 and fromholding radial cutter implant 580 in place. Wings 590, 592 and 594 aremade from Polyester (PET), Poly-Urethane (PU), Nitinol foil, Silicon,and the like.

Reference is now made to FIGS. 16A to 16D, which are schematicillustrations of a redial cutter implant, generally referenced 620,constructed and operative in accordance with a further embodiment of thedisclosed technique. Implant 620 includes four wires 622, an anchoringleaflet 624, a distal end 626 and a proximal end 628. Each of wires 622is coupled between proximal end 628 and distal end 626. Anchoringleaflet 624 extends from distal end 626, and is positioned between twoof wires 622.

Each of wires 622 is substantially similar to each of wires 474, 476,478 and 480, all of FIG. 14A. The shape of wires 622 is wider at theproximal end than at the distal end thereof. In this manner, wires 622prevent implant 620 from moving from the bladder neck into the urethra.In particular, the wider proximal portion of wires 622 is positionedwithin the bladder and the narrower distal portion of wires 622 ispositioned at the bladder neck and within the urethra. Wires 622 (i.e.,the wider proximal portion thereof) prevent implant 620 from moving outof the bladder and into the urethra by being blocked at the bladderneck.

Anchoring leaflet 624 is constructed of similar materials to those ofwires 622. Anchoring leaflet 624 is in the shape of a tongue extendingsubstantially in the proximal-normal direction (i.e., the normaldirection refers to a direction normal to the proximal-distal axis—e.g.,the dorsal direction). In this manner, anchoring leaflet 624 preventsimplant 620 from moving from the bladder neck into the bladder. Inparticular, anchoring leaflet 624 is blocked by the bladder neck suchthat implant 620 can not move into the bladder. It is noted that,anchoring leaflet 624 can be a wire leaflet (e.g., as depicted in FIGS.6A to 6D) or a full surface leaflet (e.g., substantially similar towings 590 of FIG. 15A).

Alternatively, anchoring leaflet 624, extends in the distal-normaldirection and prevents radial cutter implant 620 from moving in thedistal direction towards the urethra. Further alternatively, there areat least two leaflets 624 extending in both directions and fixingimplant 620 in place.

It is noted that, wires 622, and in particular the wider proximalportion thereof, prevent implant 620 from moving in the distaldirection. Anchoring leaflet 624 prevent implant 620 from moving in theproximal direction. Thus, implant 620 is anchored in position within thebladder neck. It is further noted that, wires 622 and anchoring leaflet624 are delivered within a sheath (e.g., implant sheath 202 of FIGS. 4Ato 4C) and are expanded (e.g., self expand upon exposure from thesheath) once positioned in the bladder neck. The number of wire 622 ofimplant 620 is at least one, and can vary. The number of anchoringleaflets 624, is at least one and can vary.

Reference is now made to FIG. 17, which is a schematic illustration of aredial cutter implant, generally referenced 650, positioned within abladder neck of a patient, constructed and operative in accordance withanother embodiment of the disclosed technique. Radial cutter implant 650includes two wires 652, an anchoring leaflet 654, a distal end 656 and aproximal end 658. Radial cutter implant 620 is substantially similar toimplant 620 of FIGS. 16A to 16D.

The distal wider portion of wires 652 is positioned within a bladder 660of a patient (not shown). The proximal narrower portion of wires 652 ispositioned within a bladder neck 662 of the patient. Anchoring leaflet654 applies a proximal radial force against bladder neck 662 therebyproducing a niche 666 within bladder neck 662. Anchoring leaflet 654 isanchored within niche 666. In this manner anchoring leaflet 654 anchorsimplant 650 within bladder neck 662. In other words, the proximal widerportion of wires 652 prevents implant 650 from moving distally (i.e.,towards a urethra 664 of the patient) and anchoring leaflet 654 preventsimplant 650 from moving proximally (i.e., towards bladder 660).

Alternatively, proximal end 658 is a substance release element, whichslowly releases substances into the bladder neck, urethra and prostateof the patient, over a period of time. The released substances caninclude painkillers, anti-inflammatory materials, anti-biotic materials,and the like. Further alternatively, implant 620 (i.e., or at least someportions thereof, such as wires 652) is covered with such materials asdetailed herein above, and releases these materials slowly into the bodyof the patient.

Reference is now made to FIG. 18, which is a schematic illustration of amethod for creating incisions in the muscles of the bladder neck byinfarction, operative in accordance with a further embodiment of thedisclosed technique. In procedure 700, the location of the bladder neckof a patient is found. With reference to FIG. 3A, the physician insertsovertube 164 into the urethra of the patient until balloon 158 is insidebladder 152. The physician inflates balloon 158 and pulls overtube 164back until balloon 158 is blocked by the bladder neck.

In procedure 702, a radial cutter implant is delivered to theconstricted location. With reference to FIG. 3B, the physician insertsdelivery 176 into positioning tube 162 and delivers radial cutterimplant 178 to the location of the bladder neck (i.e., the constrictedlocation). Alternatively, the physician delivers the implant to adifferent constricted location within the urinal system of the patientfor relieving the constriction. In procedure 704, the radial cutterimplant is released and the delivery system is removed. With referenceto FIG. 3C, the physician exposes radial cutter implant 178 from implantsheath 166. Radial cutter implant 178 expands and attaches itself to thesurrounding tissues (i.e., the wires of Radial cutter implant 178 areattached to the tissues surrounding the implant and apply pressurethereon). The physician removes delivery system 150 from urethra 154 ofthe patient.

In procedure 706, continuous pressure is applied on the tissuessurrounding the implant by employing the radial cutter implant. Withreference to FIG. 3C, the wires of radial cutter implant 178 applycontinuous pressure on the surrounding tissues. In procedure 708, at theappearance of a predetermined condition, the radial cutter implant isextracted from the patient. With reference to FIG. 3C, the physicianextracts radial cutter implant 178 from the patient at the appearance ofa predetermined condition. The predetermined condition can be thepassage of a predetermined period of time, the appearance of desiredincisions on the surrounding tissues, the appearance of a predeterminedphysiological effect, and the like.

It will be appreciated by persons skilled in the art that the disclosedtechnique is not limited to what has been particularly shown anddescribed hereinabove. Rather the scope of the disclosed technique isdefined only by the claims, which follow.

1. A urethra Implant comprising wires forming at least one closed shape,said closed shape exhibiting an expanded configuration, said closedshape being foldable into a folded configuration, said at least two ofsaid wires further being configured to extend from said foldedconfiguration to said expanded configuration such that the distancebetween sections of said wires increases, relative to said distancebetween said sections of said wires in said compressed configuration,the implant is configured to be implanted within a restricted locationof the urethra and for applying pressure on said surrounding tissue. 2.The implant according to claim 1, wherein said wires are foldable by arestrainer for enabling delivery and extraction of said removableimplant
 3. The implant according to claim 1, further comprising aproximal end coupled with at least one of said wires, said proximal endbeing tapered.
 4. The implant according to claim 1, wherein the shape ofat least one of said wires is selected from the list consisting of: theshape of said at least one of said wires being wider at the proximal endthan at the distal end thereof for preventing said removable implantfrom moving in the distal direction; the shape of said at least one ofsaid wires being wider at the distal end than at the proximal endthereof for preventing said removable implant from moving in theproximal direction; the shape of said at least one of said wires beingnarrower at the middle thereof than at the distal and proximal portionsthereof for preventing said removable implant from moving in theproximal direction and in the distal direction; and a butterfly wing. 5.The implant according to claim 1, wherein said implant being forcreating incisions is said urethra.
 6. The implant according to claim 1,wherein said implant being for the prostatic urethra.
 7. The implantaccording to claim 1, wherein said sections of said wires are lateralsections.
 8. A urethra implant comprising a flexible configurationdefining at least two longitudinal wires arranged in at least one closedshape, said closed shape exhibiting an expanded configuration, saidclosed shape being foldable into a folded configuration, said at leasttwo longitudinal wires further being configured to extend from saidfolded configuration to said expanded configuration such that thedistance between sections of said at least two longitudinal wiresincreases, relative to said distance between said sections of said atleast two longitudinal wires in said compressed configuration, theurethra implant is configured to be implanted within a restrictedlocation of the urethra whereby said at least two wires apply pressureon tissues surrounding said urethra implant.
 9. The implant according toclaim 8, wherein said at least two longitudinal wires are foldable by arestrainer for enabling delivery and extraction of said removableimplant
 10. The implant according to claim 8, further comprising aproximal end coupled with at least one of said at least two longitudinalwires, said proximal end being tapered.
 11. The implant according toclaim 8, wherein the shape of at least one of said at least twolongitudinal wires is selected from the list consisting of: the shape ofsaid at least one of said at least two longitudinal wires being wider atthe proximal end than at the distal end thereof for preventing saidremovable implant from moving in the distal direction; the shape of saidat least one of said at least two longitudinal wires being wider at thedistal end than at the proximal end thereof for preventing saidremovable implant from moving in the proximal direction; the shape ofsaid at least one of said at least two longitudinal wires being narrowerat the middle thereof than at the distal and proximal portions thereoffor preventing said removable implant from moving in the proximaldirection and in the distal direction; and a butterfly wing.
 12. Theimplant according to claim 8, wherein said implant being for creatingincisions is said urethra.
 13. The implant according to claim 8, whereinsaid implant being for the prostatic urethra.
 14. The implant accordingto claim 8, wherein said at least two longitudinal wires include lateralsections.
 15. A urethra implant comprising a flexible wire likestructure defining at least two wire like sections of finite length,coupled there-between at one end thereof, each said wire like sectionhaving a longitudinal wire portion, said flexible wire like structureexhibiting an expanded configuration, said flexible wire like structurebeing foldable into a folded configuration, said at least twolongitudinal wire sections further being configured to extend from saidfolded configuration to said expanded configuration such that thedistance between sections of said wires increases, relative to saiddistance between said sections of said wires in said compressedconfiguration, the urethra implant is configured to be implanted withina restricted location of the urethra whereby said at least twolongitudinal wire portions apply pressure on tissues surrounding saidurethra implant.
 16. The implant according to claim 15, wherein saidwire like structure is foldable by a restrainer for enabling deliveryand extraction of said removable implant
 17. The implant according toclaim 15, further comprising a proximal end coupled with said wire likestructure, said proximal end being tapered.
 18. The implant according toclaim 15, wherein the shape of at least one of said at least two wirelike sections is selected from the list consisting of: the shape of saidat least one of said at least two wire like sections being wider at theproximal end than at the distal end thereof for preventing saidremovable implant from moving in the distal direction; the shape of saidat least one of said at least two wire like sections being wider at thedistal end than at the proximal end thereof for preventing saidremovable implant from moving in the proximal direction; the shape ofsaid at least one of said at least two wire like sections being narrowerat the middle thereof than at the distal and proximal portions thereoffor preventing said removable implant from moving in the proximaldirection and in the distal direction; and a butterfly wing.
 19. Theimplant according to claim 15, wherein said implant being for creatingincisions is said urethra.
 20. The implant according to claim 15,wherein said implant being for the prostatic urethra.
 21. The implantaccording to claim 15, wherein said sections of said at least two wirelike sections are lateral sections.
 22. Urethra implant comprising atleast two closed shapes, each of said at least two closed shapes havinga proximal section, a distal section and two lateral sections extendingbetween said proximal section and said distal section, adjacent pairs ofsaid at least two closed shapes share a common lateral section, said atleast two close shapes being elastically compressible into a compressedconfiguration, said at least two closed shapes being configured toextend from said compressed configuration to an extended configuration,such that the distance between said lateral sections increases relativeto said distance there-between in said compressed configuration, eachpair of said lateral sections defining a plane, said plane excluding theremaining others of said lateral sections.
 23. The implant according toclaim 22, wherein said at least two closed shapes are foldable by arestrainer for enabling delivery and extraction of said removableimplant
 24. The implant according to claim 22, further comprising aproximal end coupled with at least one of said at least two closedshapes, said proximal end being tapered.
 25. The implant according toclaim 22, wherein the shape of at least one of said at least two closedshapes is selected from the list consisting of: the shape of said atleast one of said at least two closed shapes being wider at the proximalend than at the distal end thereof for preventing said removable implantfrom moving in the distal direction; the shape of said at least one ofsaid at least two closed shapes being wider at the distal end than atthe proximal end thereof for preventing said removable implant frommoving in the proximal direction; the shape of said at least one of saidat least two closed shapes being narrower at the middle thereof than atthe distal and proximal portions thereof for preventing said removableimplant from moving in the proximal direction and in the distaldirection; and a butterfly wing.
 26. The implant according to claim 22,wherein said implant being for creating incisions is said urethra. 27.The implant according to claim 22, wherein said implant being for theprostatic urethra.
 28. A urethra implant comprising a flexible structureincluding at least one wire like section of finite length and a flexiblerectangular section coupled there-between at the ends thereof, saidflexible structure exhibiting an expanded configuration, said flexiblestructure being foldable into a folded configuration, said flexiblestructure further being configured to extend from said foldedconfiguration to said expanded configuration such that the distancebetween said at least one wire and said rectangular section increase,relative to said distance between said at least one wire and saidrectangular section increase in said folded configuration, the urethraimplant is configured to be implanted within a restricted location ofthe urethra whereby said at least one wire and said rectangular sectionapply pressure on tissues surrounding said urethra implant.
 29. Theimplant according to claim 28, wherein said structure is foldable by arestrainer for enabling delivery and extraction of said removableimplant.
 30. The implant according to claim 28, further comprising aproximal end coupled with at least one of said at least two wires, saidproximal end being tapered.
 31. The implant according to claim 28,wherein the shape of said structure is selected from the list consistingof: the shape of said structure being wider at the proximal end than atthe distal end thereof for preventing said removable implant from movingin the distal direction; the shape of said structure being wider at thedistal end than at the proximal end thereof for preventing saidremovable implant from moving in the proximal direction; the shape ofsaid structure being narrower at the middle thereof than at the distaland proximal portions thereof for preventing said removable implant frommoving in the proximal direction and in the distal direction; and abutterfly wing.
 32. The implant according to claim 28, wherein saidimplant being for creating incisions is said urethra.
 33. The implantaccording to claim 28, wherein said implant being for the prostaticurethra.
 34. The implant according to claim 28, wherein said at leastone wire like section is a lateral section.